A Study of the Safety and Effectiveness of Infliximab in Patients With Plaque-type Psoriasis

Psoriasis Clinical Trial

Official title:

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Infliximab Induction Therapy Followed by Multiple Regimens of Maintenance InfliximabTherapy in Patients With Plaque-Type Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00106847
• Other study ID #: CR005290
• Status: Completed
• Phase: Phase 3
• First received: March 31, 2005
• Last updated: May 16, 2011
• Start date: January 2003
• Est. completion date: July 2005

Study information

• Verified date: April 2010
• Source: Centocor, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the safety and effectiveness of scheduled and as needed treatment of psoriasis with infliximab. Infliximab (Remicade) targets specific proteins in the body's immune system to help control the development of inflammation to help reduce painful disease.

Description:

This is a phase III, multicenter, randomized (patients are assigned different treatments based on chance), double-blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), placebo-controlled trial evaluating the effectiveness and safety of scheduled and as needed treatment with infliximab in patients with plaque-type psoriasis. This study will also help determine the way to use infliximab in treating patients with psoriasis.

Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures.

Patients will receive infusions of either placebo, 3mg/kg or 5 mg/kg infliximab (Remicade) at weeks 0, 2, 6 14, 18, 22, 26, 30, 34, 38, 42 and 46. Patients receive either 3mg/kg, 5 mg/kg or placebo infusions at week 0, 2, and 6. The 3mg/kg and 5 mg/kg infliximab groups then receive either every 8 week infusions or infusions as needed when their psoriasis is less than 75% improved from baseline. The placebo patients begin infliximab at week 16, 18 and 22 followed by every 8 week infusions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 683
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with diagnosis of plaque-type psoriasis for at least 6 months

• Patients with plaque-type psoriasis covering at least 10% of the body

Exclusion Criteria:

• Patients with nonplaque forms of psoriasis

• Patients who have current drug-induced psoriasis

• Patients who are pregnant, nursing, or planning pregnancy (both men and women) within 18 months of enrollment

• Patients who had any previous treatment with infliximab or any therapeutic agent targeted at reducing tumor necrosis factor

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parapsoriasis
• Psoriasis

Intervention

Drug:
• Infliximab

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centocor, Inc.

References & Publications (1)

Menter A, Feldman SR, Weinstein GD, Papp K, Evans R, Guzzo C, Li S, Dooley LT, Arnold C, Gottlieb AB. A randomized comparison of continuous vs. intermittent infliximab maintenance regimens over 1 year in the treatment of moderate-to-severe plaque psoriasi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients who achieve greater or equal to 75% improvement in Psoriasis Area and Severity Index (PASI) from baseline at week 10.
Secondary	Improvement from baseline in Psoriasis Area and Severity Index response between weeks 16 and 30. Change in Dermatology Life Quality Index from baseline at week 10. Patients with a Physician's Global Assessment score of clear or excellent at week 10.

External Links

•   A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Efficacy and Safety of Infliximab Induction Therapy Followed by Multiple Regimens of Maintenance Infliximab Therapy in Subjects with Plaque-type Psoriasis